Advanced Pelvic Floor Training Program for Prostate Cancer Surgery
Conditions
Prostate Cancer Patients Undergoing Radical Prostatectomy
Conditions: official terms
Prostatic Neoplasms - Urinary Incontinence
Conditions: Keywords
Prostate cancer, Radical prostatectomy, Pelvic floor muscle exercises, Pfilates, Hypopressives, Urinary Incontinence
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
Intervention
Name: Advanced Pelvic Floor Muscle Exercise (APFX)
Type: Behavioral
Overall Status
Recruiting
Summary
Radical prostatectomy is a common and effective treatment for prostate cancer but is associated with urinary incontinence that can persist for several months after surgery and significantly reduce quality of life. Studies have shown that routine performance of pelvic floor exercises after radical prostatectomy can aid in the recovery of urinary control; however, conventional pelvic floor exercises do not produce consistent results. Research indicates that incorporating other deep abdominal muscles can further activate the pelvic floor making it stronger than by activating the pelvic floor alone. Specifically, 'Pfilates' and 'Hypopressives' are two new techniques that combine traditional pelvic floor exercises with activation of supportive muscles. Our proposed study will be the first to test the effect of an advanced pelvic floor exercise training program that includes Pfilates and Hypopressives to treat urinary incontinence following radical prostatectomy. Our primary aim of this study is to assess the feasibility of conducting a full-scale RCT of an advanced pelvic floor exercise training program, including standard pelvic floor exercises, Pfilates, and Hypopressives techniques on urinary incontinence. Feasibility will be determined by measuring recruitment success, retention, outcome capture, and intervention adherence, tolerance, and safety. We hypothesize men under going radical prostatectomy for prostate cancer in the advance pelvic floor training program will report greater improvement in urinary incontinence and health-related quality of life.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 40 Years
Gender: Male
Criteria: Inclusion Criteria:

- Men with localized prostate cancer (stage cT1-cT2) who have consented for radical prostatectomy (open retropubic, laparoscopic, robot-assisted laparoscopic)

- Between the the ages of 40 and 80 years

- Proficient in English

Exclusion Criteria:

- i) Diagnosed with a known neurological disease, autoimmune connective tissue disorder;

- ii) Have prior experience with pelvic floor training by a healthcare provider;

- iii) Have uncontrolled hypertension;

- iv) Have diagnosed COPD (Chronic Obstructive Pulmonary Disease) and/or chronic restrictive respiratory disease; or

- v) Have a history of inguinal herniation
Location
University Health Network
Toronto, Ontario, Canada
Status: Recruiting
Contact: Daniel Santa Mina, PhD - 416-581-7565 - daniel.sta.mina@uhn.ca
Start Date
January 2015
Completion Date
July 2016
Sponsors
University of Guelph-Humber
Source
University of Guelph-Humber
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page